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linuxizer writes "Congress seems poised to turn an effort to create a pathway for generic biotech drugs, such as Remicade, into the exact opposite. Instead of the 5-year protection that traditional pharmaceuticals get, or the 0-year protection that the FTC recommends, the bill offers 12-year exclusivity with renewability for minor changes. The issue is highly charged, with activists waging a campaign to change the bill. Yet it also raises interesting questions for other technologies. To what extent do the traditional contours of patent law need to change in response to new technologies with a different set of market realities (biotech drugs are 22 times more expensive on average, and development costs for generics will be substantially higher) and in what direction? Need every new technological category get its own patent rules, and how do those rules get decided?"

Apparently the author of the summary is unfamiliar with lobbying so here goes the simplest explanation I can think of for it.

Need every new technological category get its own patent rules, and how do those rules get decided?

Depends on the leaders of that category. The people with the most money will give tiny amounts of that money to the lawmakers. Then a bill is introduced and these weird rules probably get tagged onto some bill that has a much more important focus (like health care or one of the various wars we are engaged in). Since all the lawmakers received money from the the people with money, nobody objects.

Here's one of many examples [gpo.gov] in which a bill titled "Affordable Health Choices Act" gets tiny peppering of patent law attached to it like this (which is in regards to the category 'interchangeable biological products'):

... (i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or

(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product;...

What's worse is that no voter immediately cares. Everyone cares more about things that directly affect them--like their health or their kin dying on some god forsaken soil. The immediate threat of these lobbyists is not only unseen but no one is held accountable down the line. You have to get someone not too politically savvy to be the poster child/target for this stuff if it's a whole bill you're introducing -- like Sonny Bono on copyright extension. Oh and there's another neat little thing in American politics where if you vote for that bill and then something like this gets added and you vote against the bill, your opponents label you as a "flip flopper", "waffler" or "indecisive."

Now, I paint a picture where opposition to lobbyists never arises because no one makes it a serious issue. But there are a few examples of this working positively. Example is the generic drug manufacturers do actually have some money and realize they are getting the short end of the stick so you have these lobbying wars occasionally. The really ironic thing is that name brand drugs are more expensive for the consumer. But often the consumer is on a health plan where they pay a small percentage or a copay on their drugs. If it is a copay and the consumer buys the $100/dose Calvin Klein drugs instead of the $1/dose Walmart drugs, someone (like your health care provider) is paying a lot more. Now, imagine what kind of state our health care would be in when there can't be any generic drugs for 12 years? Won't matter if you're a copay or a percentage, you'll be taking that $100/dose because it's your health and you can't exactly put a price on your health.

Reminds me of a great moment by Dr House: When he explains to his audience that Vogler's new drug will work really well, because the old drug worked really well, and nothing significant has changed, just minor changes in order to keep the patent protection.

In finland, the doctor might or might not prescribe the brand, but pharmacies where you buy the drug are by law forced to offer generic alternatives if available. The customer chooses whether he wants the generic or branded( co-pay might be bit lower on generics)

I have GERD, which mostly just means I keep tums around for when I don't or can't eat properly, and/or forget to take something better. Zantac works great, as does prilosec.

So I am down at the local pharmacy. I notice that I can get "zantac/ranitidine" for a whole range of prices, for the same doses. Then I look over and notice, that for HALF the price of the cheapest ranitidine, I can get.... cimetidine! I remembered the good Dr House's speech

> And because we're operating on the premise that making a profit selling the drug is unethical, they have no reason to start caring.

I am not sure that anyone is actually starting from that premise. Simply that the HUGE markup above marginal cost that can ONLY be supported and pay for new research though a patent regieme is perhaps not the best way of doing things. Perhaps leaving the search for new drugs to the people who look to profit from their sale leads to narrow interest in drug research since the

Seriously, we are not talking about geeks not having their OSS fix here, it is about sick people not getting their drugs. People without money are never heard of unless they retort to violence. This can be very dangerous.

This is exactly the reason democracy fails.
People need to realize, that governments aren't in no way necessary or even beneficial for healthy societies. In a world without such authorities, the success of companies would be measured solely by their ability to provide the best service to their customers. Without artificial restrictions, such as patents or copyrights, there'd never be an opportunity for a company not to try to improve their services.
A popular argument against removing patent and copyright laws is that a company has to invest significant amounts of time and money in inventing new products (such as medicine in this article's context) and that the patent would allow them to make profit out of their investment. I believe, that if a certain product really requires years of exclusive research it also isn't possible for competing companies to copy in a timeframe that wouldn't allow for the original inventor to gain reasonable profit. Nevertheless, if another company is able to provide better selling service regarding another company's invention, why not allow it? After all, we should be concerned about mankind's collective well-being and not the profit of select companies.

Without governments and their power the world would be run by gangs and mobs. End of story.

Now, on this specific issue: I don't know the best answer, and I don't know that there is a "best" answer for everybody. Basically drugs take a huge amount of money to develop and test to get approval. Remove the incentive of exclusivity in the market - so that anyone can copy it (yes, trade secret protection may still be there but reverse engineering will occur) and you will start to see very few new drugs created.

Without governments and their power the world would be run by gangs and mobs. End of story.

With governments and their power the world is run by gangs and mobs.

We just call them "governments".

Granted, the current set of Western governments is largely better than your average run-of-the-mill gangs and mobs. The same, however, cannot be said about many other current governments, nor many past Western governments.

Also "governments aren't in no way necessary or even beneficial for healthy societies." - are you on drugs? Where are these fabulous government-less utopias? "In a world without such authorities" you would be still be bartering.

You have to strike a balance between ensuring that drug development is profitable, but not excessively so - not an easy thing to do.

It's actually not hard at all to do. When you hand out monopoly rights expenses tend to rise until they take any available revenue, which means that you can basically hand them any amount of money and their expenses will rise until you obtain that balance.

Drug research doesn't need protection because it's expensive, it is expensive because it has protection. Only free market co

My comment needs to be read in the context to the one I was responding to - I don't necessarily think that drug research needs to be private, but for it to be so you need to keep it profitable (see the GP).
I'm not sure that you are fair when you say that doctors are only in it for the money - some of them work very long hours in highly stressful situations. Researchers do what they do because they are hoping to solve diseases that harm people.

Without the FDA, the research time on these drugs would be cut from 22 years to less than one. Of course, then you'd have every charlatan out there peddling his snake oil as the latest and greatest cancer cure. And without any research to back up their claims, no one would be able to judge whether or not those claims were true until after trying the drug. And if you're going to insist that companies spend billions of dollars proving their products work, then you have to also protect them and their ability to turn a profit on those products or else no one else will ever develop any.

There's a reason why the majority of drug research is done in the US: we don't force drug companies to give away their products for free. Oh, and incidentally, one of the reasons drugs cost so much here is because other countries do put price controls in place, so we end up carrying the burden for those slackers. Too bad Congress doesn't enact an export tariff on prescription drugs, we'd make enough off that to pay for healthcare.

Your comment, 22 years testing, sums it all up, That is TOO long; and the choice is not 22 years testing or no-testing it is a sensible balance, which indeed governments do seem very poor at providing.In that context also, and the US health care debate, you should know about the UK history with NICE, which was supposed to foster evidence based medicin, and did for a few yeard before becoming a contentious roadblock to new treatments.

Regulation, of Finance or Medicine is hard, because it requires common-sens

Oh, and incidentally, one of the reasons drugs cost so much here is because other countries do put price controls in place, so we end up carrying the burden for those slackers.

The main reason drugs cost so much is because the USA is one of the few countries that allows direct-to-consumer advertising of prescription drugs.Last I checked, pharma spending on advertising was 2 or 3 times its spending on basic R&D.

In case you don't understand: 2/3rds to 3/4ths the price of a prescription drug is advertising.

Drugs cost so much here because people have developed anentitlement mentality imported from Canada and Europe. Peoplethink that products that require research, development andmanufacturing should be "free". The government and insurancecompanies happily oblige and insulate everyone from the realcosts.

My wife works in pharmaceutical research. She's my source of information on how many drug trials are performed in the US versus other countries.

It doesn't matter where the companies are headquartered, it matters where they do their research and manufacturing. And the lion's share of that is done in the US.

Can't argue against anecdote:-)

Still, I'd be interested in whether the number of US trials is disproportionately higher when adjusted by GDP and population (should be around 5-6x higher than UK or Germany due to that alone), and whether those trials are actually phase 0-2 or just phase 3-4 (jumping through hoops to get FDA US approval rather than research).

Democracy fails because everyone gets to vote - including the lazy idiots who have absolutely no idea who or what they're voting for. Democracy requires an informed populace in order to work. Our populace doesn't care enough to be informed.

In a world without such authorities, the success of companies would be measured solely by their ability to provide the best service to their customers.

Wrong.

Governments are 100% necessary for the functioning of a healthy society. You ever read The Jungle [wikipedia.org]? Ever hear the term snake oil [wikipedia.org]? There's a reason the FDA exists.

Companies are not concerned about the well-being of society, they're concerned with making money. A

Which is why I would think that Health Insurance companies would be lobbying AGAINST this as well, and they are literally rolling in money. Their margin benefits greatly from getting generic drugs on the market as fast as possible.

Not about the issue itself - that may in many cases too difficult to access, the implications too hard to understand. However voters do care about corruption - they realize that a corrupt government is always a bad government. So this may be the way to discuss these issues publically: a few companies benefit from this amendment to the detriment of many other people - this is indicative of corruption.

But for these sorts of pharmaceuticals, I have to question the wisdom of allowing patents at all. Nobody really properly understands how most of this works, it's almost entirely statistics. That's not to trivialize the importance of new drugs, but patent exclusivity will discourage widespread use, reducing the statistical information we can glean from the new drugs, and making combining treatments much less safe.

Of course, the same argument works fairly well against the current pharmaceutical patent system, but again, this is Slashdot.

The purpose of patent protection is to allow the patent holder to appropriate the investment the underlying innovation requires. Without patents, the incentive to invest in R&D is diminished. The US is good at biotechnology innovation, and part of the reason for this is because biotech firms know that if their research is successful, they'll be given a chance to recuperate their investment.
Any solution to this problem has to continue to encourage research.

The purpose of patent protection is to allow the patent holder to appropriate the investment the underlying innovation requires. Without patents, the incentive to invest in R&D is diminished. The US is good at biotechnology innovation, and part of the reason for this is because biotech firms know that if their research is successful, they'll be given a chance to recuperate their investment.

Please take note of the circular nature of your argument.

Making money leads to => good biotech. Our biotech is so good because => it makes lots of $$$.

Is that the best argument you/we can come up with? -- because it makes lots of money? Shouldn't biotech be measured instead by the number of diseases it cures? or by the number of years it can push back death? and/or by the number of years it can increase our quality of life? It sounds to me like our incentives are ass-backwards. The longer we extend

If something is complicated enough to deserve patent protection, then it's complicated enough that others won't be able to easily copy the idea and compete. If an idea is trivially copied, then it's not deserving of patent protection in the first place. So all patents should be accorded the same protection: none.

If "it's complicated enough that others won't be able to easily copy the idea and compete," then you don't need a patent-- you can use a trade secret.

The original idea of patents was that the inventor gets a period of exclusivity in exchange for writing out a complete description that allows anybody skilled in the relevant art to replicate the invention. Patents and trade secrets are, in a sense, opposites.

(However, there's very little that can't be reverse engineered these day

One of the sillier posts I've seen on Slashdot in a while. Developing a new drug requires doing many, many trials to see which compounds might work, then doing many, many more trials to make sure they don't actually kill the patient or induce intolerable side effects. The end result is a proven process to create a drug that you can be reasonably sure is safe and effective. Copying this drug just means implementing the already proven process. How could this not be cheaper? If it wasn't, there'd be no generic

Without a recoup period, there is no incentive to develop new treatments. 5 years is probably a good balance. 12 is probably too long. And 0 is the type of braindead proposal you'd get at a discussion site like Digg or Fark.

When you buy your house, a lot of your money is ostensibly tossed down the drain to pay for the interest on your loan. However, this interest is actually the cost to you to borrow that money. So the lower the interest, the lower your cost to borrow money. If you had no interest to pay and had no incentive to pay back a loan on time, there simply wouldn't be a loan market. No one would lend to you because there would be no hope of getting any return on their investment. Just as you expect use of money as the benefit of borrowing, they expect a small rate of interest to recompense them for their loss of the use of the money.

In many ways, the financial and pharmalogical industries are very similar in this regard.

They already do that. The patent fees on new drugs are pretty high, especially if you count the years of research the FDA requires before allowing a new drug to be sold. It goes into the billions even for the simplest drug.

The billions of dollars required to identify potential bioactive compounds, evaluate their potential plusses and minuses, then prove to the USDA/FDA/etc. that the drug is both beneficial and safe enough for approval don't come from nowhere. The company foots the bill up front, and most of the compounds they investigate either don't work, don't work reliably, or are not safe enough for approval. The company needs to make enough profit to cover the develo

This doesn't make sense - the point of the patent is to allow the company to recoup the cost of R&D on the drug and the other drugs that didn't work out or to fund the R&D for the next drug. Buying extensions turns the research into even more of a gambling proposition - you have to have a mega drug to actually make enough to pay off your failures and even a successful drug might not break even. This would also have the effect of shrinking the number of diseases that can be profitably researched -

yeah its not like FTC know anything about trade! (did you even read [ftc.gov] their argument.)

Do you have any idea how long it takes to get drugs approved for use by the public? drugs (like software) can't simply be copied and resold, if you develop a new drug you have a good 3/4 years of no competition while a competitor gets reverse engineers it and gets approval for his version, after that you have the fact that your drugs are tried and tested and you've been producing it for 3/4 years. Patents are useful in many sectors, but medicine is even less one of them than software (especially when you consider the human cost).

IF the drug approval process was faster AND it was easy to reverse engineer drugs THEN patents are needed in medicine (probably 5 years), but until then the drug company's can shove the any proposal up their respective asses!

But you want to get rid of them because of present day technical difficulties that may one day be overcome? That's some good planning there, Lou.

Of course it is. You can always reintroduce them at that mythical day of the second coming when the unicorns finally descend to Earth and solve all problems with the patent system. Patent proponents have been saying for decades that problem X with the patent system would be solved within Y years once the system has adapted to whatever the new development challenging the patent system is (chemical processes, medicine, software, biotech, trolls, court/forum shopping, patent thickets, alternative innovation/dissemination models,...), while in practice the problems only get worse and worse (increasing examination backlogs, increasing amounts of trivial patents that get granted, increasing court case costs and associated innovation overhead/drain, legal uncertainty, various uses of patents in ways that have nothing to do with increasing innovation such as Monsanto's suing of farmers that are victims of cross-pollination and continuation patents in pharma,...)

The standard answer to remarks like this is always "don't throw away the baby with the bathwater". Reality check: the baby is long dead, now stop beating it as if it were a horse (hey, I am replying to BadAnalogyGuy).

drugs (like software) can't simply be copied and resold, if you develop a new drug you have a good 3/4 years of no competition while a competitor gets reverse engineers it and gets approval for his version, after that you have the fact that your drugs are tried and tested and you've been producing it for 3/4 years.

I don't think you know what you're talking about and neither do the mods.

In the USA, if a generic pill is shown to be identical in function to the original,the generic pill can use the original's drug trials as proof of efficacy.

I don't think you know what you're talking about and neither do the mods.

True, but short of somebody in the pharmaceutical industry correcting me, I think I can make some fairly informed guesses based of my knowledge of organic chemistry.

Not to mention that reverse engineering most drugs is a trivial act.

Of the drug yes, of the production process NO.

In the USA, if a generic pill is shown to be identical in function to the original,the generic pill can use the original's drug trials as proof of efficacy.

Drugs are rarely 100% pure, so it is unlikely that the generic pill will be identical to the original. I figured that the this would mean the new drug will need new testing & approval, to show that it's impurities are not harmful.

Still, I applaud your persistence in the face of ignorance.Most people would have done basic research in order to sustain their argument,but you bravely^W blindly charged full speed ahead with your "informed" guess.

For future reference: your informed guess wasn't worth the electricity I used to write this post.

No... the interest on the loan is 1) to cover the depreciation of the original sum, due to inflation 2) make a profit from the loan company

If there was no interest then the loan company could not make money on it, and in fact would effectively lose money.... so they would not bother, what the borrower does does not matter (they have an agreement with you, so can take you to court to make you pay)

The patent period new drugs get is there like all patents so the company can recoup the development costs, so

With all the money we donate to charities 'for the cure' or for research, I'd think the incentive would be to help people and the funding would come from numerous sources, least of which needs to be the sick person or their insurance company. Kind of like the open source movement where most people aren't doing it for the money, they're doing it for the greater good and maybe a bit of recognition.

Without a recoup period, there is no incentive to develop new treatments.

That's not entirely true. There are incentives to develop new treatments... like, you know, curing people. There might even be business models which fund developments of new treatments. It's just that there might not be business models which provide enough funding to find these treatments quickly, and what business models there are might include trying to keep trade secrets, which means that the treatments might not be widely available, and people wouldn't be able to do significant research based on thos

To encourage invention or innovation, the system MUST go back to the original reason for patent protection in the first place. The idea is that new ideas should be protected so the patent "owner" can develop said idea and turn it into a product. If there is no ability or intention to DIRECTLY make a product to take advantage of the protection, then the protection should be removed.

This means that patent trolls would all go away, since none of them have any intention to make a product based on the patents they own. It is one thing for a company like AMD or Intel to file a patent and make use of their inventions, and another for someone sitting in an office to buy a patent just so they can file lawsuits against anyone who makes a product that might infringe on the patent in question.

So, for all of these companies that file patent related lawsuits, they SHOULD be looked at to see if they have taken even a few steps towards making a product. If there has been no effort made to create a working product based on the technology, they should be fined for filing a lawsuit in the first place.

The problem with your reasoning is that it leaves no possibility for a Research and Development for-profit business. Take ARM CPUs for example. Their business model is that they develop designs for real CPU cores (which is, in a sense, a real product, but in another sense, is not). But, they are a 'fabless' semiconductor company - they don't *build* or directly sell any actual products (except for, probably, some demo/marketing units which they ship to manufacturing partners).

They license their CPU designs out to manufacturing partners, who integrate them into all sorts of devices - cell phones, game consoles, netbooks, DVRs, DVD/Blu-Ray players, automated manufacturing devices, medical devices, etc. Anything which needs a CPU could potentially use an ARM CPU design.

So, what is so *wrong* about the ARM business model? I don't think most people would call them a patent troll, and yet without patents, they would collapse overnight. But, by your (rather vague) definition, they wouldn't likely get patent protection?

ARM are actively trying to sell their designs - that's very much an indication of "intent to implement the idea".

Contrast this with Patent Trolls who get an idea and patent it (or just buy a patent) to then just sit on it until somebody else independently comes up with the same idea and DOES implement it, at which point they pounce.

Now imagine a patent system where ideas have to be implemented in a set time from filling the patent:

Playing for time by stalling (filling multiple versions) is a negative, since

Reading your post, I think you are making a logical error. Your ARM business model is producing something, a sale. They are licensing the technology they developed to other businesses and that is the way it should work.

A patent troll inherently produces nothing, they sit on knowledge waiting for someone else to (re)discover the idea and actually more forward with it. They remain uninvolved until someone else is actually producing something and then file a lawsuit.

Ahh, but, if you want to import anything into the U.S. in any quantity (obviously, you could probably smuggle small quantities and get around Customs), you have to respect patents. The U.S. Customs Service *will* seize your unlicensed products which violate patents, at the port of entry, before you can sell the goods on the market, if the patent holder complains to Customs. So, you might try to rip off ARM's designs, but you won't have any luck sellin

I would agree with this in part, as long as the attempt to sell the idea to a company counts. A classic example of where the patent system works as intended is the intermittent windshield wiper. The car companies worked to develop an intermittent wiper and were unable to do so. An independent inventor developed the idea and tried to sell it to them. They asked him to demo the idea before they would pay for it. Once they saw how it worked, they developed their own and tried to claim "obviousness". He sued them and collected significant damages.

No, he sued them and was awarded significant damages. Then he had to sue them again to collect those damages. He eventually won $10 million from Ford and $30 million from Chrysler, but spent much of it on legal bills. He was divorced. He died of brain cancer in 2005. This is not a win for the patent system.

To encourage invention or innovation, the system MUST go back to the original reason for patent protection in the first place.

To protect revenue streams, prop up failing business models and raise barriers to entry (all under the guise of "encourag[ing] invention or innovation"), the system works just fine as it is, thank you.

I know, I'm probably being far too charitable here, but it occurs to me that at least the *possibility* exists that granting longer than 5 years on drug patents *might* lead to cheaper branded drugs? 12 years might still be a bit too long, but here's my reasoning. . .

1) New drugs cost a lot of money to do R&D, and then to get through all the clinical studies and FDA approval.

2) New drugs require the drug companies to market to both doctors and patients (although, it could be argued they should be doing less marketing to patients, and more to doctors, but that's a bit off-topic for this thread). My point is, there is a 'ramp up' period to get drugs up to their 'natural' demand level (by which I mean that enough doctors and patients know about the drug that it is probably being properly prescribed to most of the patient population that needs it). This probably takes 2-5 years, I imagine.

3) The costs of R&D, trials, approval, marketing, *and* reasonable return-on-investement currently have to mostly be done within that 5 year window, which means that the cost, per patient, for the drugs, it would seem to me, must *necessarily* be quite high.

Now, if you allow the drug companies to amortize all of those 'startup' costs for the new drug over a period of say, 8-10 years, shouldn't they be able to reduce the cost-per-patient pretty substantially (assuming that the unit manufacturing costs aren't a substantial fraction [i.e. greater than 75%] of the 'retail' price the patients end up paying, which I kind of think is probably true for most drugs)?

You're assuming that someone with what amounts to a monopoly on a drug will somehow eventually want less profit and voluntarily drop their prices? Speaking of drugs, can I have some of what you're having?

I'm not really assuming any such thing. Actually, I'm assuming that the *potential* market demand (that is, the number of patients that might benefit from the drug) for most drugs is greater than the actual demand in terms of prescriptions sold to patients. (Almost) Any company will reduce its unit price *if* it has reason to believe that by lowering the unit price, it will increase sales enough to both offset the lost revenue and increase revenue overall. Put another way - there are some people who need th

"The Monopoly quantity for any good is always less than the amount produced with competition. The Monopoly price for any good is always higher than the price with any competition."

I agree with that statement, but you are comparing oranges and bananas. I never said the price, by increasing the period of patent protection, would be lower than the price with competition. What I *said* was that I think it is at least possible that the monopoly price with a *longer period* of patent protection would be lower tha

This is not a longer patent period. What this is an extension of the period that a pharma company can retain exclusive access to its clinical trial data. Without this data, a generics manufacturer couldn't get a drug to market because they would have to repeat all of the original clinical trials- something which would be extremely cost prohibitive. This bill would extend the time during which the FDA would not release the raw data from the trials to the public so that even though the patent on a drug may ha

I sincerely doubt that this is the case with Remicade on any level. Perhaps it cost a lot in R&D (I don't know), but given that it filled several niches very quickly that were desperate to be filled due to a lack of suitable medications or medications without tremendously terrible side effects (autoimmune disorders like Crohn's Disease, ulcerative colitis, rheumatoid arthritis, and ankylosing spondylitis, all of which are terrible nightmares of diseases), there was near instantaneous demand for Remicade

Anyone know how the US drug patent system works? It seems very different from my foggy memory of the system in the UK which I think is 20-25 years for drugs.

Anyway patent extension through minor changes is nothing new the drug companies have been at that one for years. Its why you get MR (modified release) slapped on the end of your medicines even though the benefit of many MR preparations isn't that great except for patient compliance issues.

Everyone has it in their heads that drug companies should get a special monopoly because drugs are so expensive. Maybe we need to knock off the special breaks and accept what our pricing signals are telling us. A lot of this stuff is simply too expensive and we need to figure out ways to make drug research less expensive.

A lot of this stuff is simply too expensive and we need to figure out ways to make drug research less expensive.

Most of the cost of drugs isn't research, it's profits. But I'm ok with 20 year patents; I wish copyrights were as sane a length.

Doctors are part of the problem. Back when I was on Paxil, the patent ran out on it. I'd been paying a $20 co-pay on a bottle (no idea what retail price was, that's another reason drugs are so expensive), as soon as the patent ran out I got generics for $5.

Next time I saw the doctor she changed the prescription to PaxilCR, which was newly patented -- and didn't work for me at all, while the old generic paroxitine did.

In fairness to your doctor, many people actually don't do well with generic substitutions, particularly for psych meds. He/She might have been trying to do you a favor and keep your medication consistent. Generics - are not the same -.

Americans have come to expect that approved prescription drugs will be safe and effective in the major of cases.

I'd settle for safe, let the market decide if a treatment is effective. The FDA should simply gather trusted, non-biased information, and let people compare treatments. There are conditions where the best treament is 40% effective at best. We'd be better served by having many more safe drugs available, and much more data.

Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

Neal Stephenson's book, "The Diamond Age," really got me thinking about matter printers. They're already here and they'll just keep getting better and better. In the near future, you'll be buying a bag of carbon pellets at the hardware store. Then, along with the design software, you'll be able to matter-print physical items. Recycling will probably get easier, also. As time progresses, the matter printers will get cheaper and more sophisticated. They will then become ubiquitous. Such devices could re

Over the years my feelings at the sight of the manifestations of shameless, corporate greed have gone from outrage to anger, and has now reached the state of pure, unadulterated loathing. It really becomes harder and harder to see anything redeeming about it, whether it is the underhanded dealings from the entertainment industry and the RIAA, or the sick greed of the likes of the medicine and GMO industry. It doesn't to be that way, it really doesn't, and it will end, one way or another.

The solution to the never ending patent rubbish that is coming out is:

1) All R&D needs to be logged (in terms of cost).2) All patents are protected and valid until the net profit of selling any item has reached the level of costs, or 1 year if no progress on the the patent has been made to monetize anything.3) After R&D costs are covered, the patent becomes public knowledge and usable in any capacity by anyone.4) Any litigation from a patent holder can only be back tracked 1 year prior to the declaration of accusation. No, oh you've been abusing my patent since 1985, cough up Billions please...

This will help innovation of new products based on older patents by opening them up as soon as they become viable.This will stop people sitting on patents (trolls).

You may ask about well, if on the day the patent opens some foreign firm floods the market in cheap XYZ drug...Well, no...Because said company may not develop until the patent has been released...Thus, the lawyers will be happy because they can still litigate companies who abuse this rule, patent holders will have a lead time to get profits, future innovators can innovate still and the whole world will advance much much quicker...

And no, I have not thought through everything and I am sure there are some holes in this that a eagle-eyed slashdotter will notice...but it could be a good starting point.

There's a massive loophole in your proposal:1. If the pharma companies are responsible for tracking the R&D costs, then they will make darn sure that the R&D costs are as high as they can be without drawing suspicion from whatever agency is enforcing these rules.2. Thanks to Hollywood accounting, the net profit of any good can be $0 (or $1 if you make a "no profit = no patent" rule) if the company producing the good wants it to be.3. Ergo, the R&D costs can either never be covered, or won't be c

1. Why? R&D costs will hurt their shareholders...It is far better for them to keep them as low as possible...And they would need to be able to prove those costs. Secondly, if they did do this then the only thing they are evidently trying to do is prevent their medication from reaching those who really need it...this would be proof of that.

2. This is fine, you could add an "upper" time limit to the patent system. However, this has to come in the same vain as simpler and more transparent accounting pra

There are several MAJOR flaws in your argument that, essentially, companies should only be able to retain exclusivity until they recoup the strict costs of their R&D on their successful projects.

First, the real costs of R&D extend will beyond just the one successful project, but generally also several failed ones. In order to break even on R&D in general, they need to recoup it on just a few of their successes. In the pharmaceutical industry, this ratio tends to be less than 1 success for ever

You forgot the creative accounting that this would inspire. I have worked with Hollywood companies; I can guarantee you that this scheme would lead to perpetual patents, as somehow the R&D costs would never be paid off. Maybe not for every invention, but for a lot of them.

I thank you for enumerating all the ways that big pharma would fail without government protection. Any business that depends on so much government protection should simply be made part of the government, and thus subject to Democratic decision making instead of private profiteering. Short of that, they should be allowed to fail just like any similarly poor business model would on the free market.

Funny you should say that. The overwhelming majority of the R&D costs are imposed by government demanding

Assuming this is true, which has to be assumed to give any credence because you give no backing material or references here whatsoever.

I have multiple and varied connections to the pharmaceutical, biotech, and medical devices industries (inside & outside, academic, research, financial, executive, etc), so I have a feel for the numbers. However, you can find confirmation of this in academic literature if you look. DiMasi asserts in a 2003 paper that the fully capitalized cost of clinical trials is 70

Well, the assumption here is that the backlog of the patent system is not reduced due to the fact that patent trolls no longer have an interest. So I would say that step 3 would be reduced to 3-6 months.

So:

1) Company starts working on developing new product on Jan. 1, 2000.2) Company finishes development on Jan 1, 2002 (2 years R&D, and, say, $1 million in costs)3) Company gets patent after reasonable time for examination/search/etc. on June 1, 2002.4) Company markets product and makes $1 million in pro

I am all for the patent system. It CAN help drive innovation. I remember back in business ethincs class in college, I learned that the guy who invented the first photo copier said he never would have invested all the time and money into it if he did not know that he was going to have exclusive rights to make it for, what is it, 18 years?

That being said, there really needs to be better patent review. There is a difference between patenting something that you spent years of R&D on, versus being a patent t

"Need every new technological category get its own patent rules, and how do those rules get decided?"

The legal answer is that Congress decides both of these issues (unless it decides to grant extended rulemaking authority to the PTO). (Currently the USPTO only has limited rulemaking authority which probably would not extend to substantive issues like term of protection).

The economic answer is that every economist will give you a different answer.

How about rather than giving 'inventors' of a drug an exclusivity period, the law gives them a compulsory license deal. Here's how it would play out:

A drug company discovers a compound or treatment process (or creates one - unlikely but not unheard of). They then register with some regulatory organization - possibly the USPTO, possibly some other more suitable entity.

At this point they receive a first rights license within that country and are guaranteed a significant percentage of any profit generated from

With Genetic Therapies [wikipedia.org] at our door step, does America really need to artificially maintain a Pharmaceutical Industry [pharmalot.com]? Wouldn't our time be better spent having University Researchers [ornl.gov] take publicly known data and start applying it to a Genetic Therapy Solutions? Rather that having Federal Funds channeled to be used as a crutch for the mercantile facade of pharmaceutical distribution, why not channel that money to University Researchers for Genetic Therapies? The FDA is more than capable of administering L

Even a cursory reading of the linked articles would show that this has almost nothing to do with patent protection, which lasts for 20 years from the date of filing regardless of the subject matter. This is all about regulatory exclusivity from the FDA. An example of regulatory exclusivity is new drug product exclusivity [fda.gov], which generally lasts for 5 years for completely new drugs and 3 years for new formulations of existing drugs. Another kind is the 180 day generic exclusivity [fda.gov] for the first generic to market, which encourages generics to be made by giving them a small window of high profitability.

The issue here is whether biologic drugs [wikipedia.org] should be given a longer than usual regulatory exclusivity period given that (so the argument goes) they are a new, experimental technology that is harder to develop than traditional small molecule drugs.

You might ask "if a drug is patented, then why is a (shorter) period of exclusivity even necessary?" Here's an example: inventor discovers a new compound that might be a useful drug. A patent is filed in 2000. Then 10 years go by while the inventor struggles to find the optimal dose and delivery mechanism. Now in 2010 the inventor's startup starts looking for a partner to bring it through trials and into production. 5 years later, human trials start. 3 years later the drug is approved by the FDA for sale. Now it's 2018 and the patent only has two years left. If the manufacturer has to recoup all of its costs in just 2 years, the price will have to be extremely high, which will limit the drug's availability. So the regulatory exclusivity period gives drug makers a guaranteed 5 years in which to recoup their costs.

So that's the argument for having an exclusivity period. There are also arguments against it, of course, but the main point is that all of this is only tangentially related to patent protection and has nothing whatever to do with a special patent rule for biologics.

thats as good as it goes. if something is so fucking valuable that it 'justifies' 13 years of 'patent duration', that means it can make heaps of money. that means, if you want to make money, you should USE it and make that money.

noone should be allowed to patent stuff, hoard them and just wait, working on other things or waiting for someone to use a similar thing and troll on them. this is knowledge. if you invented something, and are not using it, you shouldnt be able to bar mankind's progress when someone